Evidence map›Paper›PMID 42387089›Full record

Trial reportDrugs in R&D2026

Gabapentin Extended Release Tablets in Healthy Subjects Under Fed Conditions: A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Comparative Bioavailability Study.

Sudershan Kumar, Arshad Khuroo, Sanjay Jagannath Gurule, Sachin Mehra, Hari Krishan Tiwari, Y Zala, Venkata Rama Rao Kamala, Madhu Kandukuri, Shruti Dharmadhikari, Prashant Devkare and 1 more

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Drugs in R&D, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Sudershan KumarClinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Limited, Gurgaon, India.
Arshad KhurooClinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Limited, Gurgaon, India.
Sanjay Jagannath GuruleClinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Limited, Gurgaon, India.
Sachin MehraClinical Pharmacology Unit, Sun Pharmaceutical Industries Limited, Gurgaon, India.
Hari Krishan TiwariClinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Limited, Gurgaon, India.
Y ZalaFormulation Department, Sun Pharma Advanced Research Company (SPARC) Ltd, Mumbai, India.
Venkata Rama Rao KamalaFormulation Department, Sun Pharma Advanced Research Company (SPARC) Ltd, Mumbai, India.
Madhu KandukuriFormulation Department, Sun Pharma Advanced Research Company (SPARC) Ltd, Mumbai, India.
Shruti DharmadhikariMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, India.
Prashant DevkareMedical Affairs and Clinical Research, Sun Pharmaceutical Industries Limited, Mumbai, India. PrashantH.Devkare@sunpharma.com.
Chintan KhandhediaMedical Affairs and Clinical Research, Sun Pharma Laboratories Limited, Mumbai, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGabapentin is effective for treating post-herpetic neuralgia and neuropathic pain by stabilizing nerve activity through blocking calcium channels and reducing neurotransmitter release. Gabapentin is available in immediate-release (IR) and extended-release (ER) formulations. A comparative bioavailability study was conducted between Gabapentin ER 600 mg tablets once-daily (OD) (Gabantin

methodsIn this open-label, balanced, randomized, crossover study each subject received a 600 mg single dose of either T or R in Period 1, followed by crossover treatment in Period 2, with a washout period of 12 days in-between. Pharmacokinetic parameters, including C

resultsAll 24 enrolled subjects completed the study. The test formulation demonstrated comparable pharmacokinetic profile to the reference product, meeting the criteria for bioequivalence within acceptable limits (0.80-1.25). The percentage ratio for T vs R product was 0.9171 (90% confidence interval [CI] 0.826-1.0183) for AUC

conclusionsGabantin

Indexed as

AminesAnalgesicsCyclohexanecarboxylic Acidsgamma-Aminobutyric AcidAdultArea Under CurveBiological AvailabilityCross-Over StudiesDelayed-Action PreparationsGabapentinHealthy VolunteersHumansMaleMiddle AgedTabletsTherapeutic EquivalencyAminesAnalgesicsCyclohexanecarboxylic AcidsDelayed-Action PreparationsGabapentingamma-Aminobutyric AcidTablets

Identifiers

PMID42387089
PMCPMC13433685

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.